Funding for therapeutic manufacturing and testing from rapid response
platform

SIOUX FALLS, S.D.--(BUSINESS WIRE)--SAB
Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical
development company, announced today that it has been awarded a contract
for up to $5.3 million by the Biomedical Advanced Research and
Development Authority (BARDA) within the Office of the Assistant
Secretary for Preparedness and Response in the U.S. Department of Health
and Human Services (HHS). The funding will be used for advanced clinical
manufacturing and testing for SAB’s novel antibody therapeutic (SAB-301)
to treat MERS-CoV.

“SAB has developed a unique production platform to rapidly respond to
emerging infectious disease threats,” said SAB president and CEO Dr.
Eddie Sullivan. “This partnership with BARDA is instrumental in
advancing the MERS treatment, while creating a clinical development
pathway for other therapeutics produced from our novel rapid response
platform.”

SAB-301 was produced utilizing the DiversitAb™ platform, which leverages
transchromosomic cattle (Tc Bovine™). These cattle have been genetically
designed to produce large amounts of human polyclonal antibodies
(immunoglobulin G) in response to an antigen such as MERS in a brief
period of time.

Currently, there are no approved vaccines or specific treatments for
MERS, a severe respiratory disease akin to the Severe Acute Respiratory
Syndrome (SARS) with a high fatality rate. Since it was first identified
in Saudi Arabia in 2012, MERS has infected more than 1,700 people and
killed nearly 40% of those infected. According to the World Health
Organization, cases have now been confirmed in 27 countries in the
Middle East, Europe, Asia and the United States. A 2015 outbreak in the
Republic of Korea is the largest outbreak outside of the Middle East.

BARDA, which manages the procurement and advanced development of medical
countermeasures for pandemic influenza and other emerging infectious
diseases, will provide an initial $2.4M for clinical grade product for
human trials, with an option for an additional $2.9M to produce more
doses if needed.

Phase I Clinical Trials are currently underway for SAB-301 with the
National Institutes of Health (NIH) evaluating dosage and safety with a
final report expected in the first quarter of 2017. Once these trials in
healthy candidates have been completed with no significant safety
concerns, the potency and dosing of the treatment can be evaluated in
Phase 2 trials in patients with MERS in endemic countries utilizing the
product specified in the BARDA contract also conducted by the NIH.

“We are also advancing treatments for Ebola, Influenza and Zika with the
goal of leveraging our platform as a countermeasure against emerging
infectious diseases,” added Sullivan. “SAB is dedicated to partnering
with government and other organizations to address this current and
future threats to human health.”

SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a
clinical stage, biopharmaceutical development company leading the
science and manufacturing of antibody therapeutics. Utilizing some of
the most advanced antibody science in the world, SAB is delivering the
world’s first large-scale platform to create immunoglobulins. This
natural production platform holds the potential for treatment of public
health problems, rare conditions, long-term diseases and global pandemic
threats.